GxP IT Specialist

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, ProBio has a stable and high-yield viral vector platform.

Job Scope:

The GxP IT Specialist will manage and support IT systems within our GMP manufacturing facility in Hopewell, NJ. This role is crucial for ensuring compliance with FDA, GxP, and 21 CFR Part 11 regulations, supporting manufacturing and quality teams, and maintaining audit readiness. The ideal candidate should have strong experience in GxP-regulated IT environments and be skilled in validating, maintaining, and troubleshooting IT systems for GMP operations.

Key Responsibilities:

GxP Compliance & IT Support:

• Ensure all IT systems comply with GMP, 21 CFR Part 11, and Data Integrity regulations.


• Support and maintain GMP manufacturing, QC, and R&D IT systems, including LIMS, ELN, CDS, and MES.


• Collaborate with QA, QC, and Manufacturing teams to ensure audit readiness and regulatory compliance.

System Administration & Validation:

• Perform system validation (CSV), user access control, backup management, and change controls.


• Manage system qualification (IQ/OQ/PQ) and maintain IT documentation per GxP standards.


• Assist with vendor audits and IT SOP development for GxP systems.

Incident Management & Troubleshooting:

• Provide daily IT support for manufacturing and QC systems, addressing network, software, and hardware issues.


• Troubleshoot issues related to SCADA, LIMS, and other lab/manufacturing applications.


• Work with cross-functional teams to ensure data integrity and security in GxP systems.

IT Security & Data Integrity:

• Ensure secure access and data traceability for GxP systems.


• Implement cybersecurity best practices and support IT audits (internal and external).


• Manage disaster recovery plans, system backups, and business continuity procedures.

Basic Qualifications:

• Bachelor’s degree in IT, Computer Science, or related field.


• 3-5 years of experience in a GMP-regulated IT environment (Biotech, Pharma, CDMO, or similar).


• Strong knowledge of GxP, 21 CFR Part 11, Data Integrity, and CSV (Computer System Validation).


• Hands-on experience with GMP IT systems (LIMS, MES, SCADA, CDS, ELN, ERP).


• Familiarity with IT infrastructure, cybersecurity, and GxP applications.


• Experience managing FDA audits, CAPA, and IT change controls.


• Strong troubleshooting, documentation, and communication skills.

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GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.